Cleared Special

K161364 - BinaxNOW G6PD Test (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K161364 · Alere Scarborough, Inc. · Hematology device
Jun 2016
Decision
31d
Days
Class 2
Risk

K161364 is an FDA 510(k) clearance for the BinaxNOW G6PD Test. Classified as Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (product code JBF), Class II - Special Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on June 17, 2016 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7360 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K161364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2016
Decision Date June 17, 2016
Days to Decision 31 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
174d faster than avg
Panel avg: 205d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JBF Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.